J&J Violated Law for Failure to Indicate Risks in Prolift Mesh, Expert Claims
Dr. Peggy Pence, an expert on drug and medical regulation, testified in the Linda Gross trial that in addition to Ethiconâ€™s failure to obtain a clearance for the Gynecare Prolift vaginal mesh, it may have violated federal law by failing to disclose the productâ€™s risks in its labeling and other literature.
She asserted that in accordance with design control regulations, Ethicon should have identified the risks involved in the use of the Prolift based on its premarket risk analysis. It should have indicated in its labeling the tendency of the Prolift vaginal mesh to erode and cause chronic pain. The absence of long-term data to support the productâ€™s safety and efficacy was also in violation of rules and regulations.
She described as neither fair nor balanced the brochure that Linda Gross relied upon before deciding on her vaginal mesh surgery in 2006. It did not only fail to disclose the risks associated with Prolift, but it also contained statements that were not supported by evidence.
Read More: Sale, Marketing of Prolift Violated Federal Regulations, Expert Testifies